Verteporfin photodynamic therapy for neovascular age-related ...

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142 Appendix 1something to do with the sight loss. On balance, however, thechances of the treatment itself causing sight loss is very small(about 1 in a 100) and, comparatively speaking, the chances ofhaving some benefit are very high (about 1 in 3).WHAT IF SOMETHING GOES WRONG?Overall, PDT has been shown to be extremely safe. Manythousands of patients have received this treatment worldwideand the side effects are few. This treatment is now being madeavailable to you on the NHS and therefore you will be entitled tocompensation if you suffer an injury due to medical negligence.If you suffer an adverse reaction from the drug or other aspectof the treatment which is not due to negligence thencompensation will not be available.WHO IS FUNDING THE STUDYThe study is being funded by the Department of Health and theregional commissioners of specialised health services (these arethe people who provide funding to hospitals in the UK to providetreatment to people living in their region).ARE THERE ANY ALTERNATIVE TREATMENTS THAT ICAN HAVE?At present there are no other treatments which have beenshown to help patients when CNV is present under the centreof the retina. However, you do not have to agree to have thistreatment and, if you wish, we will continue to monitor youreyesight and offer you other supportive care. You can alsochange your mind at any time if you wish to be reconsidered fortreatment.WHAT IF NEW INFORMATION OR TREATMENTS BECOMEAVAILABLE?A number of new treatments for CNV are being studied butthese are still being evaluated. Being in the cohort study isunlikely to impact on your management, if a new treatment isfound to be better. Your specialist will keep you informed about
DOI: 10.3310/hta16060Health Technology Assessment 2012; Vol. 16: No. 6143any new developments and take this into consideration whileplanning your treatments.ARE THERE ANY BENEFITS FROM TAKING PART IN THISSTUDY?The various eyesight tests and the other tests which are doneto assess your suitability for treatment will be performed to highstandards which mean that the effects of treatment can beunderstood better. Also the results of the fluoresceinangiogram will be examined by experts who will provideinformation to your own specialist which may assist with yourcare. We also believe that collecting information for the studywill allow us to fine tune this treatment and help provide thebest care to others who may develop this disorder.WHEN WILL THE STUDY STOP AND WHAT WILL HAPPENTO ME AFTER THAT?We are planning to collect information for up to 3 years. Frompast experience we know that people receiving PDT are usuallykept under review for a period of 3 to 5 years. Your specialistwill decide whether you need any additional follow up evenafter this study finishes.WHAT WILL HAPPEN TO THE INFORMATIONCOLLECTED?The data which are collected will be analysed and published inmedical and other journals to inform the scientific and laypublic. It will also be made available to government bodies andhealth authorities.WHAT SAFEGUARDS ARE IN PLACE TO ENSURE THATINFORMATION COLLECTED FROM ME WILL BE KEPTCONFIDENTIAL?The details of the study have been examined carefully by theLondon Metropolitan Multicentre Research Ethics Committee,one of 13 national research ethics committees. This Committeehas approved the study, which means they are satisfied thatinformation will be kept confidential. In addition, the Royal© Queen’s Printer and Controller of HMSO 2012. This work was produced by Reeves et al. under the terms of a commissioning contract issued by theSecretary of State for Health.
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xExecutive summaryretreat on criter
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xiiExecutive summaryof data, with i
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2 Introductionon-going or new clini
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4 Introductionof VPDT in routine cl
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20 Key changes to the protocolThese
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30 Key changes to the protocolFor i
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38 Results (1) - study cohortTABLE
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46 Results (2) - objectives A, B, C
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66 Discussion of resultsStrengths a
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68 Discussion of resultsThe VPDT st
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70 Discussion of resultsOur analyse
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74 Discussion of resultsVPDT. It is
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84 References16. Stelmack J. Qualit
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86 References49. Guymer RH, Chiu AW
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88 References83. Margrain TH. Minim
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90 Appendix 1THE VERTEPORFIN PHOTOD
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Page 110 and 111: 96 Appendix 1more patients in the v
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Page 116 and 117: 102 Appendix 14. Study population4.
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Page 122 and 123: 108 Appendix 1Table 1: Schedule of
Page 124 and 125: 110 Appendix 1The Verteporfin Photo
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Page 130 and 131: 116 Appendix 1level of benefit from
Page 132 and 133: 118 Appendix 1• comparison of num
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Page 150 and 151: 136 Appendix 1Has your photographer
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FeedbackThe HTA programme and the a
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